{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Crumlin (North)",
      "state": "N/A",
      "country": "Ireland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90522",
      "recalling_firm": "Randox Laboratories Ltd.",
      "address_1": "55 Diamond Road",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide Distribution - MD, OR, PR, MT, WV",
      "recall_number": "Z-1424-2022",
      "product_description": "Randox Cholesterol-  For the quantitative in vitro determination of Cholesterol in serum and plasma.  Catalog Number: CH2O0",
      "product_quantity": "15 kits",
      "reason_for_recall": "Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.",
      "recall_initiation_date": "20220622",
      "center_classification_date": "20220720",
      "termination_date": "20240510",
      "report_date": "20220727",
      "code_info": "GTIN : 05055273201130  Lot Number: 586177   Expiry Date:  28th Jan 2024"
    }
  ]
}